eFOLDi Navigator power chair

by Suntech UK Limited

Ref STPC-A

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K243110↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR EUDAMED	Number5065002287SUN03898D Basic UDI-DI 05065002287168UDI-DI	Date8 Apr 2026Registered	StatusActive
United States	FDA 510(k) 510(k)	NumberK243110	Date8 May 2025Issued	StatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

United States FDA 510(k) Active
European Union CE/MDR Active

Specification

EUDAMED · 510(k)

Model / Reference: STPC-A

Primary DI / UDI-DI: 05065002287168
Basic UDI-DI: 5065002287SUN03898D
Direct Marketing DI: 05065002287168
EMDN Code: Y122127 Electric wheelchairs

Device Class: Class I
EU market of registration: Ireland

Manufacturer details

EUDAMED SRN: GB-MF-000025555
Authorised representative: MedPath GmbH DE-AR-000000087

Other devices from SunTech UK Ltd

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Class I
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Class I

Properties

Other properties (13)

Sterile: No
Implantable: No
Reusable: No
Contains Latex: No
Reprocessed: No
CMR Substance: No
Human-derived: No
Human Tissues: No
Animal Tissues: No
Endocrine Disruptor: No
Administering Medicine: No
Measuring Function: No
Incorporates Medicinal Product: No